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REGIMEN-SPECIFIC APPENDIX FFOR ABBV-CLS-7262

We are doing this research to find out if ABBV-CLS-7262 can help with Amyotrophic Lateral Sclerosis (ALS). We also want to find out if ABBV-CLS-7262 is safe to take without causing too many side effects.

•Ask you to complete questionnaires about your general health and well-being [Baseline Visit and Weeks 4, 8, 16 and 24/Early Termination (ET) Visits] •Collect a blood sample for:oTesting the amount of study drug in your body [Weeks 4, 8, 16, and 24/ET]oTest certain hormone levels [Regimen Screening, Week 4, 16, and 24/ET]oTest for a bleeding disorder prior to lumbar puncture [Regimen Screening if not done at Master Protocol Screening Visit, Week 16] oBiomarker (including RNA) testing [Baseline Visit, Week 8, 16, and 24/ET]oOver the course of the placebo-controlled portion of this research study, total blood draw volume for the samples listed above will be approximately 32mL or 2 tablespoons per visit •Collect a urine sample for:oRoutine safety testing [Baseline Visit, Week 4, Week 8, 16, and 24/ET]oBiomarker testing [Baseline Visit, Week 8, 16, and 24/ET]•Collect electrocardiogram (ECG) to assess for cardiovascular safety [Baseline Visit, Week 8, 16, and 24/ET]•Collect your vital signs (blood pressure, breathing & heart rate, blood oxygen level, and temperature)•Perform a lumbar Puncture to collect spinal fluid [Baseline and Week 24 Visit]•If you are a woman of childbearing potential, you will be asked to complete a Menstrual Cycle Questionnaire throughout the duration of this regimen

You will receive payment for the following: 1.stipend of $50 per on-site visit; 2.stipend of $100 per lumbar puncture (LP requested Weeks 28 and 52); 3.reimbursement for travel of $65 per on-site visit.

Yes
 

Zachary Simmons
nervemuscle@pennstatehealth.psu.edu 717-531-8257
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05740813
SITE00001309
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Inclusion Criteria:
Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
Age 18 years or older
Capable of providing informed consent and complying with study procedures, in the SI’s opinion
Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit

Exclusion Criteria:
Use of any moderate or strong CYP3A4 inhibitor or inducer within 10 days or 5 half- lives (whichever is longer) prior to Baseline and throughout the study
Abnormal adrenal function, defined as confirmed abnormal random cortisol (<5 μg/dL) or ACTH (>2x upper limit of normal) at Regimen Specific Screening.
Any clinically significant ECG abnormalities, including QT interval corrected for heart rate using Fridericia’s correction formula (QTcF) of > 450 msec for males or > 470 msec for females at Master Protocol Screening.
Neurology
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Social Values for Bird Conservation in PA

The purpose of this study is to examine public attitudes and willingness to pay for bird conversation activities on private forest lands.

No
 

Melissa Kreye
Melissa Kreye - at mxk1244@psu.edu
Ecosystem Science and Management (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013358
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Inclusion Criteria:
lives in Pennsylvania

Exclusion Criteria:
Does not live in Pennsylvania
Education
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Pictorial Influence on Sentence Comprehension

This behavioral study will examine the influence of pictorial primes on general knowledge questions. A participant will be shown a cartoon-type picture prior to the presentation of a question. They will be asked to answer the question verbally. This study aims to determine the influence of pictorial primes on memory recall and retrieval.

Yes
 

Marissa Scotto
Marissa Scotto - at mxs2620@psu.edu or 814-867-3033
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010406
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Inclusion Criteria:
Must be over the age of 18
Must be a native English speaker

Exclusion Criteria:
Under the age of 18
Not a native English speaker
Education, Language & Linguistics
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State College, PA ,

Evaluation of the Immune Response and Antigenic Signature of Patients with Babesia Infection in Pennsylvania with the Aim of Developing a Rapid Diagnostic Test

We are evaluating patients who have been infected with Babesia. Babesia is a blood parasite that is acquired from ticks. The number of cases seen in Pennsylvania every year has been increasing. We intend to evaluate the blood of patients acutely infected with Babesiosis and review for possible simultaneous co-infections. We will compare those infected patients with the blood of healthy individuals. The goal is to identify proteins in the blood of acutely infected patients that are specific for Babesia and also evaluate the prevalence of patient's who have contracted a co-infection from the tick vector that transmitted the Babesia infection. The identification of the specific bacterial/parasitic antigens could then be used to create rapid diagnostic tests and help clinicians increase awareness of these tick-borne diseases.

We will obtain basic demographic information and past medical history. We will obtain two 10ml samples of blood. The blood will then be stored and ultimately sent to Antigen Discovery, Inc for proteomic array screening.

Yes
 

David Ingram
David Ingram - at dingram@pennstatehealth.psu.edu or 717-531-8881
Medicine: Infectious Diseases and Epidemiology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011530
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Inclusion Criteria:
Healthy
18 years or older

Exclusion Criteria:
Active Cancer
History of having your spleen removed
History of liver or kidney disease
HIV
Diabetes
Infectious Diseases & Immune System
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Hershey, PA ,
Reading, PA ,
Wilkes-Barre/Scranton Area, PA ,

A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)

Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.

Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.

Yes
 

Marc Rovito
Michelle Eschbach - at meschbach@pennstatehealth.psu.edu or 610-378-2336
Cancer Institute (ST. JOSEPH)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02194738
AFFIL0A151216
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Inclusion Criteria:
Surgically resected non-small cell lung cancer
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses

Exclusion Criteria:
No patients with recurrence of lung cancer after prior resection
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Cancer
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Reading, PA ,

Rapid Motor Regulation Mechanism for Arm Movement in Response to Visual Motion

This study looks at the relationship between motor control via. arm movement and visual stimuli. After participating in brief calibration protocol for the eye tracking system, participants will be moving a robotic handle to interact with visual stimuli during various tasks. Participants will spend approximately 2 hours in the lab.

There will be one approximately 2-hour visit. They will then be asked to complete 20-25 blocks of hand movements while looking at a moving virtual stimulus with a large visual background. Participants will receive regular breaks during the experiment.

$20

Yes
 

Tarkeshwar Singh
Tarkeshwar Singh - at tsingh@psu.edu or 814-865-7851
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023522
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Inclusion Criteria:
Between 18-65 years old
Right-hand dominant
Normal or corrected-to-normal vision
Able to sit upright in a chair for long periods
Able to grasp and move objects with both hands

Exclusion Criteria:
Any history of neurological disorders
Any history of musculoskeletal disorders
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol
Medication that could make the participant drowsy or tired during the experiment
Neurology, Vision & Eyes
Not applicable
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State College, PA ,

Neurophysiological Markers of Pediatric Irritability and its Response to Intervention

This study uses specific computer tasks to predict irritability in children with Attention Deficit/Hyperactivity Disorder (ADHD), as well as the effect of ADHD medication (stimulants) on irritability symptoms in children with ADHD. Children ages between the ages of 5 and 12 years are eligible and must have an established diagnosis of ADHD or suspected symptoms of ADHD.

Yes
 

Raman Baweja
Vanessa Cao - at vcao@pennstatehealth.psu.edu or 717-531-0003, ext=285966
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT03279952
STUDY00008087
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Inclusion Criteria:
Children between the ages of 5 and 12
Children diagnosed with ADHD or suspected ADHD Symptoms
Children who are able to stop ADHD medication for testing days
Parent/child fluent in English

Exclusion Criteria:
Children younger than 5 year or older than 12 years
Children with visual or hearing deficits or sensitivity to loud noise
Neurological conditions such as active seizure disorder
Prominent traits or diagnosis of Autism, marked developmental delay, mania, psychoses, or suicidal ideation.
Children's Health, Mental & Behavioral Health
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Hershey, PA ,

Understanding healthcare workers perception and knowledge of dysphagia

The purpose of this study is to gain a greater understanding of healthcare workers’ knowledge of and perception of dysphagia in older adults. Study participants will fill out a survey/questionnaire in a single study session. This is expected to take 15-20 minutes.

You will be asked to complete a single, brief survey. It will take no more than 15-20 minutes.

No
 

Aarthi Madhavan
Aarthi Madhavan - at aarthi@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00024236
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Inclusion Criteria:
Age 18 and older
Active healthcare workers or care providers for community dwelling older adults over 60 years old
Working with older adults
English proficiency at 8th grade level

Exclusion Criteria:
Never worked with older adults
Not working clinically currently
Diagnosed mild cognitive impairment or dementia
Infectious Diseases & Immune System, Food & Nutrition, Prevention
Not applicable
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Perception of English sentences in context

This study tracks the eye movements of 30 adults to gather information on how they process sentences when presented in a context.

Yes
 

Frances Blanchette
Frances Blanchette - at fkb1@psu.edu or 814-863-7392
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007476
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Inclusion Criteria:
adult (18+)
native speaker of American English
grew up mainly in the US

Exclusion Criteria:
under 18 years of age
not a native speaker of American English
did not grow up mainly in the US
Language & Linguistics
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State College, PA ,

Genetics of Aromatase Inhibitor Musculoskeletal Syndrome (AIMSS)

This is a case-control biospecimen collection study of 1,000 breast cancer patients with survey and retrospective chart review components to study the possible genetic, clinical and demographic/lifestyle predictive factors of AIMSS.

If you decide to participate, we will ask you to send us a sample of your saliva (“spit”) and ask you to fill out a survey on a computer or on paper, whichever you prefer. The survey will ask questions about risk factor data, demographics, and questions about side effects of cancer treatments. We will also ask you for permission to collect data from your electronic medical record.

$25

No
 

Cheryl Thompson
Cheryl Thompson - at cthompson11@pennstatehealth.psu.edu
Public Health Sciences (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024358
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Inclusion Criteria:
Breast cancer (stage 0-IV) diagnosis within the last 5 years
Prescribed at least one AI as part of breast cancer treatment at least one year ago
Female aged 21 and older
English or Spanish speaking

Exclusion Criteria:
Previous diagnosis of rheumatoid arthritis
Diagnosis and systemic chemotherapy and/or hormonal treatment from cancer diagnosed prior to the index breast cancer
Those currently incarcerated
Under age 21 years old
Cancer
Survey(s)
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Mindful Moms study

This study (Mindful Moms) is being done to understand how an 8-week app-based mindfulness program called Calm impacts breastfeeding and maternal well-being. Eligible participants will be asked to complete three online surveys (each survey will take about 20 minutes) and take part in an 8-week app-based mindfulness program. Eligible participants will also be asked to take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.

Participants will take part in one of two groups: A group asked to take part in a free 8-week app-based mindfulness program on their smartphone starting when they are 36 weeks pregnant or 4 weeks after delivery. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. or A group asked to take part in a free 8-week app-based mindfulness program on your smartphone starting 4 weeks or 12 weeks after they deliver. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. Participants will also be asked to complete three online surveys (each survey will take about 20 minutes) and take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.

$130

No
 

Amy Moore
Amy Moore - at amm9107@psu.edu or 814-865-6714
Center for Childhood Obesity Research (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018380
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Inclusion Criteria:
18 years of age or older
currently pregnant (12 to 34 weeks) or recently delivered (within the past 4 weeks)
intend to or are currently breastfeeding
daily access to a smartphone
willing to download a free mobile app

Exclusion Criteria:
have a current daily meditation practice
Food & Nutrition, Pregnancy & Infertility, Women's Health
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KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA

Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.

The purpose of this voluntary research study is to compare any good and bad effects of using the study drug, pembrolizumab, plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.

Yes
 

Mitchell Machtay
igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03546582
STUDY00017112
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Inclusion Criteria:
Confirmed diagnosis of recurrent or any new primary squamous cell carcinoma of the head and neck
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck

Exclusion Criteria:
Patients with distant metastases
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
Cancer
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Hershey, PA ,

Phase II Trial of Palbociclib with Fulvestrant in Individuals withHormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor

In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.

Participants will be required to come to the clinic every three weeks for evaluation and fulvestrant injections, take medication correctly, keep all appointments.

Yes
 

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02738866
STUDY00010878
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Inclusion Criteria:
Men and women, 18 years of age or older
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:
Women who are pregnant or breast-feeding
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
Cancer
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Hershey, PA ,

SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations

Microcystic lymphatic malformations (mLMs) are masses of spongy tissue that may have small fluid-filled cysts. They are made of abnormally large or misshapen lymph vessels that do not work correctly. They are usually present at birth and get worse over time. Complications of mLMs include infection, bleeding, leaking of lymphatic fluid, disfigurement, and impaired mobility. The purpose of this study is to find out if the study medicine, sirolimus 3.9% topical gel, can help with the treatment of mLMs.

Total duration of the study is approximately 14 months, with up to 8 visits (approximately 1 visit per month). 5 visits will occur in person and 3 visits will be phone call visits. You will also complete 2 interviews. After the first 14 months, you will have phone call visits every 84 days until either the study is discontinued, or you decide to no longer participate. Procedures involved in the study include: medical history collection, physical exams, skin assessments, patient interviews, photographs, blood draws (at 3 visits), urine tests, and questionnaires.

Yes
 

Andrea Zaenglein
DermatologyClinicalTrials@pennstatehealth.psu.edu 717-531-5136
Dermatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06239480
STUDY00024161
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Inclusion Criteria:
Confirmed diagnosis of microcystic lymphatic malformation
At least 6 years old
Willing to follow all study guidelines

Exclusion Criteria:
Certain treatments are not allowed; coordinator will discuss specific treatments
History of HIV or other immunodeficiency
Skin Conditions
Prefer not to display
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Hershey, PA ,

Depressive Symptomatology and Inflammation

The purpose of this research is to investigate the associations between depressive symptoms and inflammation. The researchers are studying how specific symptoms of depression (such as fatigue, sadness, impaired concentration, and loss of pleasure) are related to markers of inflammation, which is a key component of our immune system. Volunteers with depressive symptoms, as well as volunteers without depressive symptoms are needed for this research study. This study includes an online survey to determine eligibility and one in-lab visit. Participants who are eligible will be scheduled for one in-lab visit (2.5-3h for participants with depressive symptoms &amp; 1-2h for participants without depressive symptoms), where they will be asked to answer surveys with questions related to depressive symptoms and complete a number of tasks (using an iPad and a touch screen phone) that measure thinking skills including attention, memory and reaction time. Participants will also undergo a single blood draw to assess inflammatory markers.

Participation will require one in person visit at the CRC that takes from 1 to 1.5 hours total where they will have their blood drawn, fill out surveys about their mood, and complete cognitive tests.

30

Yes
 

Molly Wright
Molly Wright - at mpw5810@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011171
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Inclusion Criteria:
Fluent in English
No history of depression
Free of chronic inflammatory or autoimmune disorders
If female, not pregnant or nursing

Exclusion Criteria:
Personal or family history (first-degree relatives) of major depressive disorder or major psychiatric illness
Taking non-steroidal anti-inflammatory agents or statins everyday within the past month
Taking antipsychotics or mood stabilizers
If female, are post-menopausal or pregnancy/lactation
Infectious Diseases & Immune System, Mental & Behavioral Health
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State College, PA ,

Pilot Study to Assess Medication Adherence, Health Literacy, and Technological Literacy among African Americans and Latinos with Hypertension

This pilot study aims explore the health literacy and medication adherence found among African Americans and Latinos with hypertension receiving care at Hamilton Health Center in Harrisburg PA. We also aim to determine the feasibility of the iPad or smartphone as a tool for accessing health related information among African American and Latino patients with hypertension receiving care at clinics at Hamilton Health Center in Harrisburg PA. The expected outcomes of this project are to obtain a better understand of the literacy levels and adherence behaviors of African Americans and Latinos in Harrisburg, Pennsylvania. The findings from this study will provide valuable insights into the health management behaviors of this community and determine if there is a need to develop a mobile health application for the management of hypertension.

Yes
 

Yendelela Cuffee
Yendelela Cuffee - at ycuffee@phs.psu.edu or 717-531-2044
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00005986
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Inclusion Criteria:
Diagnosed with high blood pressure
Prescribed medication for high blood pressure
African American/Black (Hispanic or Non-Hispanic) or White (Hispanic)
21 years and older
Able to speak and read English

Exclusion Criteria:
Unable to provide consent to participate in the study
Heart & Vascular, Diabetes & Hormones
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Hershey, PA ,

Comparison of Two Methods of Genre-based (Research Article) Writing Instruction

The different effects of genre-based writing instruction and integration of technology use in genre-based writing instruction will be examined. The specific genre for this study is a research paper. Different patterns of instructor-learner interaction in both instructional situations will also be investigated.

There will be three in-person visits for instructions on academic writing. Pre- and Post-instructions questionnaires and reflective journals will be collected.

Yes
 

Minjin Kim
Minjin Kim - at mmk6337@psu.edu or 814-883-1023
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019764
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Inclusion Criteria:
master's students
non-native English speakers
adults older than 18 years old
active student enrolled at University Park campus
living in the United States

Exclusion Criteria:
native English speakers
younger than 18 years old
not living in the United States
Education, Language & Linguistics
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State College, PA ,

CO-CREATION OF DIGITAL TOOLKITS FOR ENHANCING THE RESILIENCE OF LOW-INCOME HOUSING IN SELECTED LOCATIONS IN FLORIDA AND PENNSYLVANIA

This study aims to assess engineering design solutions for sustainable, low-cost housing which can be able to withstand extreme heat and flooding disasters. The information will be used in digital toolkits and platforms to provide recommendations to residents in this area to learn the options they can use to make their housing resilient to extreme events and how they can access the information to guide them in the creation of resilient, sustainable and affordable houses in flood and extreme heat prone areas.

The study will interview the subject matter experts for a maximum of one hour to obtain their experiential input on engineering design recommendations in Flood and extreme heat-prone areas in Florida and Pennsylvania. The interview will be on zoom

No
 

Esther Obonyo
Lorine Ouma - at lao5206@psu.edu
School of Engineering Design and Innovation (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020638
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Inclusion Criteria:
Above 18 years
All genders
Only Subject matter experts working with academic institution, Non-profit organizations and networks, government and private sectors, research centers and are in the field of housing, natural disasters, climate change adaptation and humanitarian response

Exclusion Criteria:
Below 18 years
Adults who are not subject matter experts of housing, natural disasters, climate change adaptation and humanitarian response
Any adult who qualifies for the inclusion criteria but does not wish to take part in the study
Education
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PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy

The purpose of this study is to find out what effects, good and/or bad, study treatment with talazoparib in combination with the chemotherapy drugs topotecan and gemcitabine has on pediatric patients with acute myeloid leukemia (AML) that has returned or has not responded to treatment. The study drug talazoparib has been chosen because there is evidence that is can reduce tumor activity in a more specific way than chemotherapy.

If you join the study, you will given a certain dose of the study drug talazoparib, and of the chemotherapy drugs topotecan and gemcitabine. You may be asked to provide biological samples (such as blood or bone marrow) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will have 2-3 months of active participation, including collection of information from you, admission to the hospital for a minimum of 5-7 days, and at least weekly visits to the study center.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT05101551
SITE00001417
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Inclusion Criteria:
Ages ≥ 21

Exclusion Criteria:
Patients with down syndrome
Cancer
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Hershey, PA ,

Exploring the Needs and Challenges of Care Partners to Support Financial Management of Individuals with AD/ADRD

The project focuses on gathering initial evidence about the opportunities and challenges of designing tailored financial technology (fintech) to support the care partners of persons living with Alzheimer’s disease (AD) and AD-related dementia (ADRD) to help them with collaborative and longitudinal financial management. To accomplish this goal, we will conduct 20 min survey study and optional follow-up interview activities with care partners.

We are recruiting care partners of individuals living with Alzheimer's Disease and Alzheimer's Disease Related Dementias. There will be two phases in the study. The first phase is a 20-min survey that will ask participants about their financial management behavior. The second phase is optional, and it is a 40-min follow-up interview with similar questions.

For the first phase, each participant may choose to enter a drawing for a chance to win a $50 Amazon eGift card. For the second phase, each participant will receive a $30 Amazon eGift card for their time.

No
 

Ling Qiu
Ling Qiu - at lzq5034@psu.edu or 402-416-5975
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023385
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Inclusion Criteria:
Care partners of individuals living with Alzheimer's Disease and Alzheimer's Disease Related Dementias
Ability to understand or speak English
Age range: over 21 years and less than 89 years.

Exclusion Criteria:
Minors, under age 21
Non-English-speaking respondents
Those who are NOT care partners of individuals living with Alzheimer's Disease and Alzheimer's Disease Related Dementias
Mental & Behavioral Health
Survey(s)
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BCC015: Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

This is a study of the drug DFMO (difluoromethylornithine) for neuroblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.

You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as CT scans and MIBG or PET scans. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04301843
STUDY00015051
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Inclusion Criteria:
Up to 31 years old with history of relapsed/refractory neuroblastoma.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy

Exclusion Criteria:
Received a dose of DFMO in combination with etoposide
Currently receiving another investigational drug
Cancer
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Hershey, PA ,

Feasibility of Immersive Virtual Reality (iVR) Dietician Program in Patients with Metabolic-dysfunction Associated Steatotic Liver Disease (MASLD)

Our team has created and validated an iVR dietician program known as the Immersive Virtual Alimentation and Nutrition (IVAN). The goal of this project is to translate the IVAN program to practice and community research. We plan to accomplish this by performing a randomized clinical trial evaluating the effect of the IVAN program in combination with synchronous audio/video dietary counseling on self-reported dietary intake and weight compared to in-person counseling. Concurrently, we will provide a survey assessing implementation outcomes to both groups as well as our team's dietician at each study visit, and crossover the intervention at study completion so all participants assess the IVAN program. Additionally, we will have ourclinic health care providers experience the IVAN program and assess implementation outcomes.

Participants will be randomly assigned to receive one of the two study treatments, either the standard of care in-person dietary education with a dietician or the experimental treatment using iVR for dietary education in conjunction with a dietician. Participants will complete a dietary intake assessment tool and measure their weight using a scale provided by our team starting the week before the first dietary education visit. Participants will continue to weigh themselves at least once weekly and additionally complete the dietary intake assessment on 5 weeks over the course of the study. Each dietary intake assessment includes 2 weekdays and 1 weekend. Participants will attend 3 sessions in Penn State’s Clinical Research Center over 12 weeks for either 30 minutes of dietary education from a either dietician or the iVR program. In either case, there will have an additional 30 minutes of time with the dietician for questions and discussion. Participants will complete a survey associated with the education session at each visit. Participants are free to skip any question he/she would prefer to not answer. We anticipate the survey will last no more than 30 minutes.At the final study session, certain participants will also undergo a liver ultrasound (Fibroscan) based on the date of their most recent Fibroscan. This is expected to last no more than 30 minutes.

100

Yes
 

Justin Tondt
StineLaboratory@pennstatehealth.psu.edu
Family and Community Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06215131
STUDY00024998
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Inclusion Criteria:
Metabolic fatty liver disease on imaging
Possession of a smartphone

Exclusion Criteria:
Inability to provide informed consent
Institutionalized/prisoner
Pregnant
Other causes of hepatic steatosis or chronic liver disease
Digestive Systems & Liver Disease
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Hershey, PA ,

Using grip force as a measure of fear in humans during a robot guided haunted house scenario

The objectives of the study are to determine whether grip force is related to participants’ fear and whether touch feedback from a robot can effectively communicate risk in a simulated high stress environment. We hypothesize that grip force increases in stressful situations like walking through a haunted house. Like in a real haunted house, people often find comfort in holding hands with someone as they walk through. In this study, a participant walks through a virtual haunted house.

There will be one in person visit. Participant will wear VR equipment and chest heart rate monitor. They will hold a virtual robot's hand and walk through a VR haunted house environment until it is over. They will then answer a brief survey.

15

Yes
 

Alan Wagner
Savanna Spazak - at szs685@psu.edu or 724-705-4893
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023827
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Inclusion Criteria:
An adult over the age of 18
Must not be suffering from anxiety disorders and/or panic attacks.
Must not be suffering from any known heart conditions.
Must not, to your knowledge, be prone to nausea when experiencing VR

Exclusion Criteria:
Under 18
Motion sickness caused by VR
Heart problems
Anxiety disorder
prone to nausea in VR
Not applicable
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State College, PA ,

Investigating the effect of restaurant environment on food intake using mixed reality application.

This study investigates the influence of different rest design of restaurant on participants’ food consumption behavior. More specifically, visually pleasant versus visually unpleasant design elements are included in two cafe settings to study their influence on participant liking, and emotion response. To accomplish this, we will conduct an experiment where participants will be eating a meal while immersed in a virtual café interior with two different designs using a VR headset. Their food intake will be measured.

Participants will visit the lab for 3 sessions to eat a meal each time while wearing an immersive virtual reality headset.

$30 amazon gift card

Yes
 

Travis Masterson
Keerthana Govindarazan - at kmg6763@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00024330
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Inclusion Criteria:
Between the ages of 18-65
Fluent in English
Free of self-reported food allergies
No diagnosis of cognitive or physical disabilities that may affect appetite or eating behaviors
No diagnosis of disabilities that may affect sensory proprioception related to virtual reality

Exclusion Criteria:
Are younger than 18 or older than 65 years of age
Not fluent in English
Have self-reported food allergies
Have a diagnosis of cognitive or physical disabilities that may affect appetite or eating behaviors
Have a diagnosis of disabilities that may affect sensory proprioception related to virtual reality
Not applicable
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State College, PA ,

Satisfying Competing Task Goals While Walking on Different Paths

As we walk, we have to achieve different task goals: stay on the path, keep moving forward, maintain balance, etc. This study will test young healthy adults walking on various types of paths to determine how they negotiate achieving these various task goals. We predict that for different walking tasks, these healthy adults will make different trade-offs between which goals to achieve in a systematic and predictable way.

There will be one in-person visit lasting no more than 3 hours. Participants will be asked to perform some basic vision, reaction time, and balance tasks. Participants will then be asked to walk on a treadmill in a virtual environment under a variety of conditions where the visual scene and/or paths being walked on change from trial to trial.

$20

Yes
 

Jonathan Dingwell
Anna Render - at LoCoLab@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014157
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Inclusion Criteria:
Age 18-35 years old
Body Mass Index (BMI) ≥ 18 and ≤ 30
Blood pressures with systolic < 140 and diastolic < 90
Corrected visual acuity (Snellen chart) ≥ 20/40 with both eyes open
Able to walk un-assisted for at least 5 minutes without shortness of breath, chest pain, or joint pain in the legs, neck, or back

Exclusion Criteria:
All persons failing to meet any of the inclusion criteria listed above will be excluded
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State College, PA ,

Parallel Phase III Randomized Trials For High Risk Prostate Cancer Evaluating De-Intensification For Lower Genomic Risk and Intensification for Higher Genomic Risk with Radiation (NRG-GU009) (PSCI# 20-141)

This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cancer.

This study is being done to answer the following questions:If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment?If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cance

Yes
 

Joseph Miccio
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04513717
SITE00000914
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Inclusion Criteria:
Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days
High-risk disease
ECOG Performance Status of 0-2 within 120 days prior to registration
Adequate hematologic function within 120 days prior to registration
Adequate hepatic function within 120 days prior to registration

Exclusion Criteria:
Prior radical prostatectomy
Prior systemic chemotherapy within ≤3 years prior to registration
Current use of 5-alpha reductase inhibitor
Didanosine (DDI) antiretroviral therapy is not permitted
History of seizure disorder or current severe or unstable angina
Cancer
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Hershey, PA ,

Lexical and sentence processing in novice L2 learners: Psycholinguistic and neurocognitive investigations

We are studying how children and adults learn second languages in the classroom. To do this, we ask children and adults to read words or sentences in English and in Spanish while we record brainwaves using noninvasive sensors. The participant wears a cap that looks like a swimmers cap with the sensors attached to it.

Yes
 

Adriana (Janet) van Hell
Katharine Donnelly Adams - at kda11@psu.edu
Psychology (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
PRAMS00041301
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Inclusion Criteria:
Adults enrolled in third semester (intermediate) Spanish
Middle school students enrolled in first year Spanish
Monolingual English speaker
Right-handed
Normal or corrected-to-normal vision

Exclusion Criteria:
Not fluent in any language other than English
History of neurological disorders
Uncorrected vision
Education, Language & Linguistics
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State College, PA ,

The Blended4Blues Study

An intervention using an internet-based platform for coping and mood difficulties. Participants will be able to use cognitive-behavioral therapy (CBT) based online self-help modules over the course of a 10-week program.

Participants will engage with online materials on a weekly basis for 10 weeks.

$25

No
 

Michelle Newman
Jeremy Schwob - at jts462@psu.edu or 314-458-7375
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00018688
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Inclusion Criteria:
Have access to a computer and/or or mobile phone with an internet connection and data plan allowing 90 min spent on treatment per week.
U.S. resident currently residing in the United States
Fluent in the English language in terms of speaking, listening, reading, and writing.
Aged 18-19 years
Presence of depressive symptoms as measured by a score ≥ 10 on the QIDS-17-SR

Exclusion Criteria:
Not a U.S. resident currently residing in the United States
Unable to speak, read, listen, and write English fluently.
Do not meet inclusion criteria for clinical depression on the QIDS-17-SR, i.e., score ≥ 10
Does not fulfill DSM-5 Criteria for MDE on the MINI Clinical Interview.
Expressed suicidal ideation defined as score >1 on the suicide ideation item on the PHQ-9, and/or on the MINI.
Mental & Behavioral Health
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An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients

The purpose of this study is to test the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy)

•Blood collection for laboratory tests•CT/MRI/PET/CT scans•ECG•Take study drug•Tumor assessment

Yes
 

Joseph Drabick
Laurie ONeal - at loneal1@pennstatehealth.psu.edu or 717-531-0003, ext=343429
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03567889
SITE00001259
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Inclusion Criteria:
Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable).
Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion
Males or females, age ≥ 18 years
ECOG Performance Status/WHO Performance Status ≤ 1.
Life expectancy of > 24 months

Exclusion Criteria:
Uveal melanoma or mucosal melanoma
Evidence of distant metastases at screening
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ
Presence of active infections
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Using Apple Watches to Assess Substance Co-use in Young Adults (Project SPARC Pre-Pilot): a Feasibility Study

In this study, we aim to investigate the feasibility and usability of using Apple Watches to collect substance co-use data, as well as contextual data that could potentially be associated with substance co-use data (location, social context, mood, health, etc.)

No
 

Saeed Abdullah
Saeed Abdullah - at saeed@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017735
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Inclusion Criteria:
Between 18-25 years of age
Currently owns and uses an iPhone with iOS version 15 or newer
Currently owns and uses an Apple Watch with watchOS version 8 or newer
Determined eligible through screener

Exclusion Criteria:
Eligibility determined using a screening survey
I'm interested
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